Urinary tract infections (UTI)
associated or not with prostatitis or epididymitis caused by
susceptible strains of organisms.

Respiratory infections, caused
by susceptible strains of organisms.

4.3 Contraindications

Marbofloxacin should not be used
in dogs aged less than 12 months, or less than 18 months for
exceptionally large breeds of dogs, such as Great Danes, Briard,
Bernese, Bouvier and Mastiffs, with a longer growth period.

Do not use in animals with known
hypersensitivity to marbofloxacin or other (fluoro)quinolones or to
any of the excipients of the product.

Do not use in case of confirmed
or suspected resistance to fluoroquinolones (cross resistance).

Do not use in cats. For the
treatment of this species, a 5 mg tablet is available.

4.4 Special warnings for each
target species

A low urinary pH could have an
inhibitory effect on the activity of marbofloxacin.

4.5 Special precautions for
use

Special precautions for use in
animals

The fluoroquinolones have been
shown to induce erosion of articular cartilage in juvenile dogs and
care should be taken to dose accurately especially in young
animals.

Some fluoroquinolones at high
doses may have an epileptogenic potential. Cautious use is
recommended in dogs diagnosed as suffering from epilepsy.

Fluoroquinolones should be
reserved for the treatment of clinical conditions which have
responded poorly, or are expected to respond poorly to other
classes of antimicrobials. Whenever possible, use of
fluoroquinolones should be based on susceptibility testing. Use of
the product deviating from the instructions given in the SPC may
increase the prevalence of bacteria resistant to the
fluoroquinolones and may decrease effectiveness of treatment with
other quinolones due to the potential for cross-resistance.

Special precautions to be taken
by the person administering the veterinary medicinal product to
animals

People with known
hypersensitivity to (fluoro)quinolones should avoid contact with
the veterinary medicinal product.

In case of accidental ingestion
seek medical advice immediately and show the package leaflet or the
label to the physician.

Wash hands after use.

4.6 Adverse reactions (frequency
and seriousness)

At the therapeutic recommended
dosage, no severe side-effects are to be expected in dogs.

Mild side effects such as
vomiting, softening of faeces, modification of thirst or transient
increase in activity may occasionally occur. These signs cease
spontaneously after treatment and do not necessitate cessation of
treatment.

Hypersensitivity (allergic)
reactions may occur in treated animals. In the case of allergic
reaction, the treatment should be withdrawn.

There was no significant development, evolution or spread of
resistance in pathogenic strains isolated from diseases in
companion animals, since the use of marbofloxacin on the veterinary
market. The incidence and the degree of transfer
ofgenetic resistance may be
considered as very low.

Cross-resistance to beta-lactam
antibiotics, aminoglycosides, tetracyclines, macrolides and
polypeptide antibiotics, sulfonamides, nitrofurans and
diaminopyrimidines generally does not occur. However, certain
mutations causing resistance to marbofloxacin, can also cause
resistance against cephalosporins, tetracyclines, macrolides and
chloramphenicol.

5.2 Pharmacokinetic
particulars

After oral administration in
dogs at the recommended dose of 2 mg/kg, marbofloxacin is readily
absorbed and reaches maximal plasma concentrations of 1.5 µg/ml
within 2 hours.

Its bioavailability is close to
100%.

It is weakly bound to plasma
proteins (less than 10%), extensively distributed and in most
tissues (liver, kidney, skin, lung, bladder, digestive tract) it
achieves higher concentrations than in plasma. Marbofloxacin is
eliminated slowly (t½ß = 14 h in dogs) predominantly in the active
form in urine (2/3) and faeces (1/3).

6. PHARMACEUTICAL
PARTICULARS

6.1 List of excipients

Lactose monohydrate

Cellulose microcrystalline

Povidone K90

Purified water

Crospovidone

Meat flavour

Silica, colloidal anhydrous

Magnesium stearate

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf-life of the veterinary
medicinal product as packaged for sale: 3 years.

Shelf-life of halved tablets: 7
days.

See also section 6.4.

6.4. Special precautions for
storage

This veterinary medicinal
product does not require any special storage conditions.

In case of using halved tablets:
Return any remaining half tablet to the opened blister pocket. Use
the remaining half tablet for the next administration.

See also section 6.3.

6.5 Nature
andcomposition of immediate
packaging

The product is packaged in
aluminium – PVC/aluminium/polyamide blister.

Box of 1 blister of 10
tablets

Box of 2 blisters of 10
tablets

Box of 10 blisters of 10
tablets

Not all pack sizes may be
marketed.

6.6Special precautions for the disposal of unused
veterinary medicinal product or waste materials derived from the
use of such products

Any unused veterinary medicinal
product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local
requirements.